Status:
NOT_YET_RECRUITING
A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
Lead Sponsor:
ImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.
Conditions:
Neuromyelitis Optica Spectrum Disorder (NMOSD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.
Detailed Description
This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, p...
Eligibility Criteria
Inclusion
- Age 18 to 70 years, inclusive, at the time of informed consent
- Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
- Confirmation of NMOSD diagnosis with AQP4+ antibodies
- The EDSS score should be ≤7.0
- Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening
Exclusion
- Have received rituximab or other anti-CD20 drugs treatment within 6 months
- Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
- Females who are pregnant or lactating.
- Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 10 2026
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06557174
Start Date
October 10 2024
End Date
July 10 2026
Last Update
August 16 2024
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